Medical Tubing and Extrusion

Medical tubing and extrusion technologies

FDA hits Olympus with warning letters after factory inspections

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The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

“Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements,” the company said in a statement to MassDevice sister site Medical Design & Outsourcing. “For that reason, we are committed to working together with FDA to address concerns.”

Get the full story at Medical Design & Outsourcing.

About Jim Hammerand

Jim Hammerand is the managing editor of Arrowfly's MassDevice and Medical Design & Outsourcing, where he leads coverage of medtech innovation, design, engineering and manufacturing. He also contributes to our Devicetalks podcasts and live events. Hammerand has more than two decades of journalism experience spanning newspapers, magazines, websites, live events, radio and TV news. For nearly a decade, Hammerand reported and edited business news for American City Business Journals as a reporter and digital editor at the Minneapolis/St. Paul Business Journal and then as managing editor of the Puget Sound Business Journal in Seattle. He holds degrees in journalism and management from the University of Minnesota and has won journalism awards from the Society of Professional Journalists, American Society of Business Publication Editors, and Trade, Association, Business Publications International. Connect with him on LinkedIn or by email at [email protected].